The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 5 No.
6 • December 2002
In questions of power, let no more be
heard of confidence in man, but bind him down from mischief by the chains of the
What a glorious morning this is!
Samuel Adams, comment to John Hancock
at the Battle of Lexington, April 19, 1775
We have it in our power to begin the
world over again.
Thomas Paine, Common Sense, 1776
Folds—The First Amendment Wins After 8 Years of Battle
was indeed a glorious morning. On December 18, 2002, Ari Fleischer announced
that the president and the new FDA commissioner, Mark McClellan, had met and
were announcing that the FDA would be making available much more information
about the health effects of dietary supplements, as well as foods, in a new FDA
initiative called Better Health Information for Consumers. See www.cspan.com for
the White House briefing by Ari Fleischer for Dec. 18, 2002.
the same day, the FDA sent out a press release, “FDA Announces Initiative to
Provide Better Health Information for Consumers,” which explained how health
claims can be used in labels and in advertising that meet a new “weight of the
scientific evidence” standard. (Up to now, the FDA has required health claims
for foods or dietary supplements to meet an as yet undefined “significant
scientific agreement” standard, which virtually demanded the near certainty of
a scientific consensus.) The new qualified claim would require that the
manufacturer provide a credible body of scientific data supporting the claim and
show that the “weight of the scientific evidence” supports the claim. The
FDA could require a disclaimer to prevent any potential misleading. The FDA
press release can be downloaded from www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html.
FDA also issued, on December 18, a “Guidance for Industry: Qualified Health
Claims in the Labeling of Conventional Foods and Dietary Supplements.” (Copies
of this document can be obtained by calling 301-436-2317 or by faxing a request
to 301-436-2636 or from the Internet at www.cfsan.fda.gov/~dms/guidance.html or
their “Guidance,” the FDA reviews the events leading up to this new policy.
The FDA makes it clear that this major new policy change is intended to
implement the court’s rulings in Pearson v. Shalala. The FDA’s new
understanding of the requirements to meet Pearson are discussed in detail and is
a 180º change from their prior willful misunderstanding. The proposed changes
to the FDA health-claims process were those we had long been arguing for, most
recently in a 160-page Public Comment submitted to the FDA in response to their
call in the Federal Register for public comments on how the FDA could
regulate labels and advertising and still comply with the First Amendment (our
Public Comment is available at www.emord.com).
most exciting part of this decision to bring the FDA into compliance with the
First Amendment is a consideration of the changes that will quickly occur as a
result. We will almost immediately see many petitions for health claims, both by
dietary supplement and food companies. Reliable health information available to
consumers in the marketplace will be increased manyfold in a few years. The
availability of useful information on how to reduce the risks of medical
conditions and manifestations of aging will provide much needed competition with
the pharmaceutical industry. That industry will have to find new models for
business than merely one in which profits are made by investing huge amounts of
money in developing patented blockbuster drugs that are then sold at high prices
as a monopoly for limited periods of time. For example, a health claim that
omega-3 fatty acids (as found, for example, in coldwater fish oils) markedly
reduce the risk of cardiovascular disease (CVD), especially sudden death from
CVD, will allow competition with some CVD drugs on the market at much higher
prices and with much greater potential for serious adverse side effects.
ten years, we doubt that much will remain of the conventional foods that are
most of what you find in a modern supermarket or fast food emporium. Instead you
will find functional foods, that is, foods in which particular natural
ingredients with healthful properties are increased and undesirables are
reduced, either by fortification or by breeding or genetically engineering new
and better forms of edible animals and plants. Biotechnology will win over
consumers not by saving farmers money on pesticide use, but by making foods more
healthful. For example, some scientists have already developed a tomato that
contains greatly increased levels of lycopene, and we have reported previously
on the high-amylose-starch potato created by genetic engineering that results in
a slowly digested potato with a greatly reduced glucose spike.
sum, this new policy will help create and expand a free market in medicine.
ends? Yes, there always are some. We will not be finished with the FDA until it
allows health claims for foods and dietary supplements that can be used to treat
diseases, not just help prevent diseases. This, too, is a First Amendment issue.
If information on a treatment use for a dietary supplement or food is truthful
and nonmisleading, then the government has no authority to prohibit it. Yet the
FDA still stands firm against such treatment claims. We can expect the
pharmaceutical industry to continue to fight these claims. A suit has already
been filed on these issues. A health-claims petition had originally been filed
by Dr. Julian Whitaker, ourselves, and others that asked the FDA to approve a
claim that saw palmetto could reduce the symptoms of mild benign prostatic
hypertrophy. The claim is truthful and nonmisleading, yet the FDA refused even
to review the claim, saying that this is a “treatment” claim and, hence, was
not covered by the DSHEA’s provisions for health claims. The DSHEA, however,
permits truthful claims for “any nutrient-disease relationship.” Moreover,
if the Congressional statute did not permit truthful “treatment” claims,
then it would be unconstitutional, being a violation of the First Amendment. The
case, where we sued the FDA on both statutory and First Amendment grounds for
its unwillingness to review the saw palmetto health claim, is now awaiting
decision before a judge of the district court of the District of Columbia. If we
lose, then we’ll appeal. Presumably the FDA will do the same if it loses. The
final loose end is this: As we interpret it, the First Amendment (“Congress
shall make no law . . . abridging the freedom of speech, or of the press . .
.”) provides that we need no go-ahead or authorization or approval from the
government in order to communicate truthful, nonmisleading information. We
shouldn’t need to ask the FDA’s permission before speaking. But we feel that
it will take another two or three Clarence Thomases—Clarence Thomas believes
that “commercial speech” should receive as much First Amendment protection
as any other kind of speech—on the U.S. Supreme Court before we can win this.
heartfelt thanks to our coplaintiffs,* especially Julian Whitaker, M.D., in this
8-year and continuing litigation effort and to Jonathan Emord for making this
great victory possible with his brilliant legal skills and principled commitment
to the First Amendment. Plus our special thanks to those of you who are not
coplaintiffs but who donated money to help us pay for this protracted battle; we
hope you will feel now that it was worth every penny. We are about to enter a
wonderful new world where it will be far easier to live a very long and healthy